Dear Consultant,
Hiring R&D Scientist - Formulation Scientist physical pharmacy, physical chemistry and solid state characterization (DSC, XRPD etc.) (Pharmaceuticals/Biotechnology/Clinical Research) 2-10Yrs, 53LPA- 71LPA (~ $75,000.00-$100,000.00 USD), New York, USA
3CCIPLA/R&DScFORMULATIONsC210Y5371LNEWYORKUSA/11500$31120
About Company: InfoInvaGen Pharmaceuticals, Inc., a Cipla subsidiary
Job Details
Experience: 2 - 10 Years
Annual Salary: 53LPA- 71LPA ($75,000.00-$100,000.00 USD)
Work Location: Central Islip, New York, USA
Domain: Pharmaceuticals/Biotechnology/Clinical Research
Job Description
This candidate needs to be a formulation scientist with experience in physical pharmacy, physical chemistry and solid state characterization (DSC, XRPD etc.).
The best school for this discipline is Purdue University Indianapolis.
The R&D Scientist position is an individual contributor role and reporting to a Manager or Senior Manager of Research & Development (R&D) at InvaGen/ Cipla New York.
This candidate needs to be a formulation scientist with experience in physical pharmacy, physical chemistry and solid-state characterization (DSC, XRPD etc.).
THE JOB DUTIES FOR THIS POSITION INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING:
· Operate as the subject matter expert (SME) on pre-formulation and formulation or process development or technology transfer or analytical sciences as applied to development, characterization,
· Process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products.
· Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner.
· Conduct API, excipient, packaging or device characterization; excipient compatibility and forced degradation studies.
· Recommend stage appropriate acceptance criteria for vendor and regulatory specifications.
· Utilize relevant theoretical modeling and statistical tools, as required.
· Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE).
· Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.
· Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction.
· Develop and implement strategies to control related substances, where applicable.
· Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.
· Lead and/or participate in activities related to process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders.
· Operate as the subject matter expert (SME) on analytical methods for various internal and external projects.
· Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods;
· US FDA or EU guidance and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.
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· Act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.
· Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.).
· Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
· Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions.
· Independently draft and/or review standard operating procedures (SOPs).
· Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.
· Draft and/or participate in drafting relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j) submissions.
· Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.
· Train peers and junior staff members on new techniques.
TYPICAL DAY-TO-DAY ACTIVITIES
· New product development.
· R&D activities such as pre-formulation, formulation, process development or analytical method development.
· Technical Troubleshooting.
· Technology Transfer.
· Process Validations.
· Method Validations.
· New Analytical Method Development.
· Leading activities at CROs and CMOs.
· Drafting dossier supportive documents
· Drafting and responding to relevant requests from the US FDA or EU authorities
· Working with external partners on technical activities
EDUCATION AND EXPERIENCE
· Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
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· In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.
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· In-depth understanding of various pre- formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.
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· Experience with pilot-scale and manufacturing-scale equipment is a plus.
· Experience with process analytical technologies (PAT) is a plus.
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· In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques such that IR is a must.
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· Experience with analytical techniques such as Dissolution, Particle Size Analysis, dynamic vapor sorption (DVS), x-ray powder diffraction (XRPD),
mass spectrometry (MS), nuclear magnetic resonance (NMR) etc. is a plus.
· In-depth understanding of theoretical principles of laboratory analytical techniques is a must.
PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLS
· Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
· Strong command over written and verbal English is a must. Past publication experience is a must.
· Must be able to work under minimal supervision and able to work independently and in a team environment.
· Must be able to exercise appropriate professional judgment on matters of significance.
· Must be proficient in computer skills and software applications such as Microsoft Office tools.
· Knowledge of statistical packages is a plus.
· Must communicate clearly and concisely across levels, both orally and in written.
OTHER JOB INFORMATION
· Relocation negotiable
· No remote work available
· Must be willing to work some weekends based on a relevant business need, if required.
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 (Pharmaceuticals/Biotechnology/Clinical Research) 2-10Yrs, 53LPA- 71LPA (~ $75,000.00-$100,000.00 USD), New York, USA 3CCIPLA/R&DScFORMULATIONsC210Y5371LNEWYORKUSA/11500$31120){kind=link}
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